Senior Biostatistician

Everest Clinical Research Overview

We are a full-service contract research organization providing expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. Our team serves top companies worldwide and works on advanced drugs, biologics, and medical devices in development.

The company was established in 2004 with a strong foundation as a statistical and data management center of excellence. We have expanded our services and successfully developed ourselves as a full-service CRO. Our headquarters are located in Markham (Greater Toronto Area), Ontario, Canada, with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China, and Taipei, Taiwan.

We are known for high-quality deliverables, superior customer service, and flexibility in meeting clients' needs. As a dynamic organization with an entrepreneurial origin, we continue to experience exceptional growth and great success.

To maintain this success in the clinical research field, we seek skilled individuals to join our winning team as Senior Biostatisticians at our Markham, Ontario location or remotely from a home-based office in accordance with our Work from Home policy.

Key Responsibilities:

1. Leadership and Project Management:
   • Lead efforts in resolving day-to-day work-related issues and problems, securing quality, improving efficiency, and productivity of statistical and programming operations.
   • Apply project management skills, statistical, and programming techniques to lead assigned projects; achieve quality and on-time delivery of deliverables, earn client trust, and repeat business.
2. Statistical Planning and Methodologies:
   • Provide statistical expertise for design, analysis, and reporting of clinical trials and research projects.
   • Contribute to the writing of statistical sections of study protocols, perform sample size calculations, develop randomization specifications, and generate randomization codes.
   • Create and maintain Statistical and Programming Quality Control (QC) and QA Plans for assigned projects.
   • Provide input to unblinded data management plans when required.
   • Assist in research and development of statistical methodologies and processes.
3. Statistical Programming:
   • Develop and/or review ADaM dataset specifications. Review and provide input to SDTM dataset specifications when required.
   • Perform QC validation of analysis datasets and TLGs.
   • Participate in third-level review of dry runs and final runs.
   • Lead statistical dry runs and final runs by actively participating or contributing to project and resources management, addressing statistical and programming questions, and interacting with data management to follow up and resolve data issues.
   • Review and provide input to the Analysis Data Reviewer's Guide, discuss and incorporate Data Standards Reviewer's review comments to ensure quality of the document.
4. Statistical Analysis and Reporting, and Publication Support:
   • Perform statistical analysis as per SAP and address peer/QC review comments and findings.
   • Perform statistical validation of core results, address additional QC validation comments and findings on the core results.
   • Plan and conduct or contribute to trial results reporting/dissemination meetings.
   • Under supervision contribute to the contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness, and appropriateness of the interpretation of the statistical results.
   • Write statistical reports or statistical sections of the CSR.
   • Perform statistical analyses for publications, including abstracts, manuscripts, presentations, and posters.
5. Supporting Clinical Data Collection and Cleaning:
   • Provide statistical input to Case Report Forms (CRF) design and database/variable structure.
   • Provide statistical input to non-CRF data collection and acquisition methods and approaches.
   • Review Data Management Plan sections relating to critical data collection and cleaning. Provide statistical input to Data Validation Specification.
   • Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution.
   • Perform ongoing assessment and communication of data quality issues, including protocol deviations.
   • Assist data management and trial management teams in preparing for database lock.

Estimated Salary Range: $85,000 - $110,000 per annum

Qualifications and Experience:

A Ph.D. degree in statistical science, mathematical analysis, or related fields plus 2 years highly relevant experience or a Master's degree plus 4 years highly relevant experience, with demonstrated ability and sustained performance.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities. Upon request, we will provide accommodations for candidates participating in any part of our recruitment and selection process.